Betaserc

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Betaserc(Serc)

8 mg, tablets

Betahistini dihydrochloridum
Betaserc and Serc are different trade names for the same medicine.

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• It is necessary to keep this leaflet, so that it can be re-read if necessary.
• It is necessary to consult a doctor, pharmacist, or nurse in case of any doubts.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If any side effects occur, including any possible side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed.

Table of contents of the leaflet

• 1. What is Betaserc and what is it used for
• 2. Important information before taking Betaserc
• 3. How to take Betaserc
• 4. Possible side effects
• 5. How to store Betaserc
• 6. Contents of the packaging and other information

1. What is Betaserc and what is it used for

What is Betaserc

Betaserc contains betahistine. Betaserc is a type of medicine called a "histamine analog".

What is Betaserc used for

Betaserc is used to treat Meniere's disease, which is characterized by the following symptoms:

• dizziness (with nausea, vomiting)
• progressive hearing loss
• tinnitus

In the symptomatic treatment of dizziness of vestibular origin.

How Betaserc works

Betaserc works by improving blood flow in the inner ear. This reduces increased pressure.

2. Important information before taking Betaserc

When not to take Betaserc

• if the patient is allergic (hypersensitive) to betahistine or any of the other ingredients of Betaserc (listed in section 6)
• if the doctor has diagnosed the patient with a pheochromocytoma (a tumor of the adrenal gland) Do not take Betaserc if any of the above applies. In case of doubts, consult a doctor or pharmacist before taking Betaserc.

Warnings and precautions

Before taking Betaserc, consult a doctor or pharmacist if:

• there have been stomach ulcers
• there is asthma If any of the above applies (or doubts arise), consult a doctor or pharmacist before taking Betaserc. The doctor may want to closely monitor the patient while taking Betaserc.

Children

Betaserc is not recommended for use in children under 18 years of age.

Other medicines and Betaserc

Tell the doctor or pharmacist about all medicines being taken, including those obtained without a prescription and herbal medicines.
In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• antihistamines - they may (theoretically) affect the action of Betaserc. Betaserc may also reduce the effect of antihistamines.
• monoamine oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. They may enhance the effect of Betaserc If any of the above applies (or doubts arise), consult a doctor or pharmacist before taking Betaserc.

Betaserc with food and drink

Betaserc can be taken with or without food. However, Betaserc may cause mild stomach discomfort (listed in section 4). Taking Betaserc with food may help reduce stomach discomfort.

Pregnancy, breastfeeding, and fertility

It is not known whether Betaserc affects the fetus:

• stop taking Betaserc and inform the doctor if the patient is pregnant or suspects pregnancy.
• do not take Betaserc during pregnancy, unless the doctor decides it is necessary.

It is not known whether Betaserc passes into breast milk:

• do not breastfeed while taking Betaserc, unless the doctor allows it.

Driving and using machines

It is unlikely that Betaserc will affect the ability to drive or use tools and machines.
However, remember that the diseases being treated with betahistine (Meniere's disease and dizziness) can cause dizziness and nausea and may affect the ability to drive or use machines.

3. How to take Betaserc

Betaserc should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

• The doctor will adjust the dose according to the patient's condition.
• continue taking the medicine. It may take some time for the medicine to start working.

How to take the medicine

• swallow the tablet and drink water.
• the tablet can be taken with or without food. However, Betaserc may cause mild stomach discomfort (listed in section 4). Taking Betaserc with food may help reduce stomach discomfort.

How much to take

Betaserc is available in two strengths: 8 mg and 24 mg. The usual dose is:

• Betaserc, 8 mg - one or two tablets three times a day.

if taking more than one tablet a day, spread the doses evenly throughout the day, e.g., take one tablet in the morning and one in the evening. try to take the tablets at the same time every day. This will ensure a constant amount of medicine in the body.
taking the medicine at the same time will also help remember to take it.

Taking more Betaserc than prescribed

if a higher dose of Betaserc is taken than prescribed, nausea, drowsiness, or stomach pain may occur. in case of doubts, consult a doctor.

Missing a dose of Betaserc

• if a dose of Betaserc is missed, take the next dose at the scheduled time.
• do not take a double dose to make up for the missed dose.

Stopping Betaserc

do not stop taking Betaserc without consulting a doctor, even if an improvement occurs.
in case of further doubts about the use of the medicine, consult a doctor or pharmacist.

4. Possible side effects

like all medicines, Betaserc can cause side effects, although not everybody gets them. after taking this medicine, the following side effects may occur:

Allergic reactions

if an allergic reaction occurs, stop taking Betaserc and consult a doctor or go to the nearest hospital immediately. the symptoms may be:

• red or lumpy skin rash or skin inflammation with itching
• swelling of the face, lips, tongue, or throat
• low blood pressure
• loss of consciousness
• difficulty breathing

stop taking Betaserc, consult a doctor or go to the hospital immediately if any of the above symptoms occur.

Other side effects:

Common(occurring in less than 1 in 10 people):

• nausea
• digestive disorders
• headache

Other side effects that have been reported while taking Betaserc

• mild stomach discomfort, such as vomiting, stomach and intestinal pain, bloating, and gas. taking Betaserc with food may help reduce stomach discomfort.

Reporting side effects

if any side effects occur, including any possible side effects not listed in the leaflet, inform the doctor, pharmacist, or nurse.
side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309;
website: https://smz.ezdrowie.gov.pl
reporting side effects will help gather more information on the safety of the medicine.

5. How to store Betaserc

• store in a place out of sight and reach of children.
• store at a temperature not exceeding 25°C, in a dry place.
• do not use Betaserc after the expiry date stated on the packaging. the expiry date refers to the last day of the month stated.
• medicines should not be disposed of via wastewater or household waste. ask a pharmacist how to dispose of unused medicines. this will help protect the environment.

6. Contents of the packaging and other information

What Betaserc contains

• the active substance is 8 mg of betahistine dihydrochloride, which corresponds to 5.21 mg of betahistine.
• the other ingredients are: microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silica, talc.

What Betaserc looks like and what the pack contains

Betaserc 8 mg betahistine dihydrochloride is available in the form of round, flat, white to almost white tablets with beveled edges. they have a diameter of 7 mm and are engraved with "256" on one side.
Betaserc, 8 mg is available in packs of 30 tablets, packaged in PVC/PVDC/Al blisters.
for more detailed information, contact the marketing authorization holder or the parallel importer:

Marketing authorization holder in Spain, the country of export:

Neuraxpharm Spain S.L.U.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona, Spain

Manufacturer

Mylan Laboratories SAS
Route de Belleville Lieu dit Maillard
01400 Châtillon sur Chalaronne
France

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Spain, the country of export: 733469.9
Parallel import authorization number: 310/19

Date of leaflet approval: 05.08.2024

[Information about the trademark]